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Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

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ClinicalTrials.gov Identifier: NCT00748241
Recruitment Status : Completed
First Posted : September 8, 2008
Results First Posted : February 15, 2012
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Jaw, Edentulous, Partially
Intervention Device: Astra Tech Fixture ST
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Period Title: Overall Study
Started 19
Completed 11
Not Completed 8
Reason Not Completed
Implant failure             1
Lost to Follow-up             5
Death             2
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
61.0  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
2
  10.5%
Male
17
  89.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Implant Survival Rate
Hide Description An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame At follow-up visit: 6 months after implants have been loaded
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description:
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Number of Participants Analyzed 14
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
53
Measure Type: Number
Unit of Measure: Percentage of implants
89.9
2.Primary Outcome
Title Implant Survival Rate
Hide Description An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame At follow-up visit: 1 year after implants have been loaded
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes subjects who completed 12 month visit.
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description:
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Number of Participants Analyzed 15
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
52
Measure Type: Number
Unit of Measure: Percentage of implants
89.9
3.Primary Outcome
Title Implant Survival Rate
Hide Description An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame At follow-up visit: 2 years after implants have been loaded
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes subjects who completed 24 month visit.
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description:
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Number of Participants Analyzed 13
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
43
Measure Type: Number
Unit of Measure: Percentage of implants
89.9
4.Primary Outcome
Title Implant Survival Rate
Hide Description An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Time Frame At follow-up visit: 3 years after implants have been loaded
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes subjects who completed 36 month visit.
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description:
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Number of Participants Analyzed 11
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
39
Measure Type: Number
Unit of Measure: Percentage of implants
89.9
5.Secondary Outcome
Title Implant Failure
Hide Description Total number of implants reported as failure.
Time Frame 3 years after implant placement
Hide Outcome Measure Data
Hide Analysis Population Description
Number of failed implants based on total number of patients enrolled and total number of placed implants
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description:
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
70
Measure Type: Number
Unit of Measure: Number of implants
7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Astra Tech Fixture ST
Hide Arm/Group Description Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
All-Cause Mortality
Astra Tech Fixture ST
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Astra Tech Fixture ST
Affected / at Risk (%) # Events
Total   2/19 (10.53%)    
Injury, poisoning and procedural complications   
Drug overdose  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory arrest  1/19 (5.26%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Astra Tech Fixture ST
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Head of Clinical Research Area Dental
Organization: Astra Tech AB
Phone: +46317763000
Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT00748241     History of Changes
Other Study ID Numbers: YA-MIC-0002
First Submitted: September 5, 2008
First Posted: September 8, 2008
Results First Submitted: August 23, 2011
Results First Posted: February 15, 2012
Last Update Posted: February 15, 2012